United States Pharmacopeia reference standards

United States Pharmacopeia. Reference standards are requited in many USP and NF tests, and in a few FCC tests. The USPC distributes such standards domestically and has authorized international distribution by a number of organizations or companies. There are well over 1000 USP Reference Standards, including several for melting points, and also specimens of narcotics and other controlled substances. New standards are constantly under development as needed in various USP, NF, and FCC testing methods. 

A statement of each method used in the testing of the sample. The statement shall indicate the location of data that establish that the methods used in the testing of the sample meet proper standards of accuracy and reliability as applied to the product tested. (If the method employed is in the current revision of the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or in other recognized standard references, or is detailed in an approved new drug application and the referenced method is not modified, a statement indicating the method and reference will suffice). The suitability of all testing methods used shall be verified under actual conditions of use. 

The United States Pharmacopeia-National Formulary (USP-NF), USP34-NF29 SI. General Requirements/< > JSP Reference Standards, pp 38-40. Pharmacopeial Forum 35(6) 1507... 

Reference Standards Some instrumental and chromatographic tests and assays specify the use of a reference standard. Where a reference standard is designated as USP, it may be obtained from the United States Pharmacopeia, 12601 Twin-brook Parkway, Rockville, MD 20852 . Where a reference standard is designated as a NIST (National Institute of Standards and Technology) Standard Reference Material, it may be obtainedfrom the Standard Reference Materials Program, NIST, 100 Bureau Drive, Stop 2322, Gaithersburg, MD 20899-2322 . 

The standard chemical and biological methods of analysis are those accepted by the United States Pharmacopeia XXlll as well as the ones accepted by the AO AC in 1995 (81—84). The USP method involves saponification of the sample (dry concentrate, premix, powder, capsule, tablet, or aqueous suspension) with aqueous alcohoHc KOH solvent extraction solvent removal chromatographic separation of vitamin D from extraneous ingredients and colormetric determination with antimony trichloride and comparison with a solution of USP cholecalciferol reference standard. 

Several years after the successful launch of a new product, it is typical for North American pharmaceutical firms to become involved in the United States Pharmacopeia-National Formulary (USP-NF) revision process to allow inclusion of their API and formulations in the USP-NF. The USP-NF and their supplements are a compilation of monographs prepared under the authority of the Pharmacopeial Convention. The purpose of the USP-NF and supplements is to provide authoritative standards and specifications for materials and substances and their preparations that are used in health care or for the improvement or maintenance of health.16 The revision process— as outlined in the USP-NF—begins with inquiries, comments and suggestions for revision in the USP-NF text mailed directly to the USP.17 Participation in this process ensures consideration of the innovator s methods, specifications, and reference standards for inclusion in the USP-NF. Approval for inclusion in the USP-NF is gained after consideration by an Expert Committee of the USP Council of Experts. If the Expert Committee so recommends, the proposed revision is published in the Pharmacopeial Forum (PF) for review and comments by interested readers of the PF. The comments and data submitted by interested readers are reviewed and addressed, and the Expert Committee then decides whether to recommend to the USP Council of Experts that the proposed revision should be adopted in the USP-NF. 

United States Pharmacopeia Rev. 25 and National Formulary. 20th ed. Preface/Preample Technical Facts on Reference Standards, p. xlvi, 2002. 

Natamycin is included in the United States Pharmacopeia [3], in the Code of Federal Regulations as drug substance [4] as well as food additive [5], and in the Minimum Requirements for Antibiotic Products of Japan [6]. The microbiological activity of natamycin is expressed in fig anhydrate per mg. The FDA master standard has an assigned potency of 922 fig of anhydrous natamycin per milligram. This standard is identical to Gist-brocades natamycin trihydrate reference standard lot 711-EN-78-1. 

USP Reference Standards Catalog. United States Pharmacopeia, 12601 Twinbrook Park way Rockville, MD 20852 1790, USA. 

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